Tubular ampoule closure



June 12, 1951 M. L.. LocKHART 2,556,331

TUBULAR AMPOULE cLosURE Filed April 1, 1946 I INVENTOR Mars/all Zw/(ladri linto a vein or large blood vessel.

has pierced through to a blood Vessel.

Patented June 12, 1951 "UNITED STATES PTENT oFFlcE l TUBULAR AMPOULE CLOSURE Marshall L. Lockhart, Rutherford, N. J.

Application April 1, 1946,- Serial No. 658,670

(Cl. 128-220l Claims.

This invention relates to a structurally and `functionally improved closure and in its more specific aspects aims to providel a closure or jstoppe'r particularly intended for use withjam- Q'pules or similar containers for medicaments which are to be injected into tissues by a hypodermic needle. y

This application is a continuation-impart of the prior application which resulted in U. S.

doned.

@In the practice of medicine, it is frequently .necessary to resort, to hypodermic injections. Certain of these are of the intravenous type. Most of them are of the subcutaneous and intermuscular type. In other words, the medicament which is to be injected should not be expressed Therefore, correct medical technique has called, in such type of injections, for the piercing of the skin and underlying tissues by a hypodermic needle toa proper depth. Thereupon, the practitioner has endeavored to ascertain whether the cannula Such piercing has been evident by a low of blood through the bore of the cannula and outwardly ofthe same to a point where it might be observed bythe practitioner. If the needle tip extends in toa vein, then the physician or person administeringl the hypodermic should withdraw the same andjrepeatthe entire operation in a diierent locale so that the needle would not extend into alb'lood vessel. Only after he has assured himself "':that-merely an intermuscular or subcutaneous injection would occur is the medicament expelled through thecannula or needle into the tissues.

, Where ampule syringe assemblies have in effect provided a sealed chamber, it has been extremely difficult for the practitioner to determine Whether the needle has been extended to a point or at a location such that it was lodged in a vein. As AWill be understood, with the inner end of the needle extending into, or being in direct communication with,Y a sealed chamber such as an ampule or the barrel of the syringe, a pressure condition has existed such that blood spurting inwardly through the bore of the cannula could not iloW from the inner end of the same to be part of the hypodermic syringe assembly, it will*l be feasible for the practitioner to quickly determine whether or not the needle is properly disposed in the tissues, or in other Words, not in a vein. This will be because with an aspirating type of closure it will be' feasible to `vary the pressure conditions in an otherwise pressurestable chamber or container so that if the needle is lodged in a vein a certain amount of blood may readily iiow through the bore of the cannula to be visible to the practitioner.V

A further object is that of providing a closure which may embody one of a number of different designs such that it is capable of ready association with an ampulev or the barrel of a, syringe and which closure may be operated to cause an aspirating effect to result without substantially' prolonging the over-all period of hypodermic injection.

A further object is that of providing a stopper or closure which will embody a simple design and structure capable of operating under virtually all conditions governing hypodermic injection technique and which closure may be manufactured in quantities at nominal figures by automatic machines and methods.

With these and other objects in mind, reference is had to the attached sheets of drawings illustrating practical embodiments of the invention, and in which:

Fig. 1 is a sectional side view of a part of a syringe assembly and showing one form of closure in association therewith; l

Fig. 2 is a similar View of an ampule, the medicament of which is maintained in position by means of a closure constructed in accordance with the present teachings;

Fig. 3 is a fragmentary `sectional view of a cylinder barrel and showing an alternative form of closure plug in association therewith;

Fig. 4 is a sectional side View of an ampule with still another form of closure associated therewith and also showing a portion of a syringe in opera tive relation with respect thereto; and

Fig. 5 is a sectional side view of a single-ended ampule, its end being sealed by a closure of the present type.

In Fig. l, there has been shown one unit or barrel of a hypodermic syringe assembly. This may include a body I5 in the form of a cylinder and conveniently constructed of plastic material. A boss I6 may project from this body and serve as a mounting for a double-ended needle I1. A plunger or thrust portion I8 conveniently extends rearwardly within the barrel of body I5 to a point short of its inner end. As shown, this portion concentrically disposed with respect to and spaced from both the adjacent needle body as well as the inner face of the barrel I5. The inner or rear end of the body may be provided with extensions or flange portions I9. To supplement the finger-engaging parts thus provided, a metallic plate or collar 20 may encircle the barrel I5 and lie in contact with the face of the portions I9.

A syringe such as the foregoing should be provided with a closure such that its interior will be maintained in clean condition. This closure may also serve as an actuator for an ampule to be associated with the syringe. In accordance with the present teachings, the closure may include a body 2|, preferably formed of rubber, and hollowed out and recessed to provide what might be termed a chamber portion 22. The end of this portion is closed by a relatively thin part of the body 2-I to provide a bowed diaphragm portion 23. A flange 24 may extend from the body 2| and lie in contact with the inner face of the barrel bore adjacent the end of the same. With the parts thus disposed, it is obvious that the barrel will be effectively sealed against the enl trance of foreign material.

In using a syringe of this type, the physician or technician will determine the locale of the injection and will thereupon exert an axial thrust upon the assemblysuch that the outer end of the needle I'I will pierce the skin and underlying tissues. In thus moving the parts, the second and ythird fingers may underlie the flange portions |9 and plate or'collar 20. The thumb may press against the outer face of the body 2 I. With the closure 2| in position, it is obvious that a sealed chamber is provided by the bar-rel I5 with the needle embedded in the tissues. Therefore, a condition is present which would usually prevent a seepage of blood through the bore of the needle and from its inner end, even if the outer end of the needle were lodged in a vein.

'Howeven due to the diaphragm portion 23 of the closure, it is feasible to exert an aspirating action. In other words, the diaphragm 23 may be flexed by the thumb or otherwise. Incident to such flexing, the pressure within the barrel I5 will be varied. Accordingly, if the needle I1 be disposed within a vein, blood may in limited quantities be discharged from the inner end of the needle within the barrel. Such discharge of blood will be readily visible to the physician or other technician making the injection. If such 'flow occurs, it will be apparent that the needle is lodged in the vein and that it should be withdrawn and a second piercing of the tissues effected before medicament is discharged.

If, in response to the aspirating action of the closure 2-I, no flow of blood occurs, then such closure may be removed and an ampule filled with medicament may be disposed within barrel I5. Conveniently, the closure 2| is applied to or mounted upon the outer end of such an ampule which may thereupon be freely projected with respect to the syringe barrel as shown in Fig. l. Such projection will result in a piercing of the usual ampule closure by the inner end of the needle. Continued projection of the ampule will cause its stopper or closure to come into contact with the` plunger portion I8, thus causing the stopper to act as a piston. This will serve to express medicament through the needle bore and into the tissues of the patient. After such injection has once been made, the needle may be withdrawn from the tissues and the syringe assembly discarded. Otherwise, after such withdrawal, the parts may be cleaned and sterilized yso that they may be reused.

In Fig. 2, an ampule such as is usable with the parts of the syringe assembly shown in Fig. l has been illustrated. In that view, the numeral 25 indicates the ampule body formed of glass or other `suitable material and which body is conveniently provided with a central, transverse, and imperforate partition 26.l Medicament indicated at 21 may vill one of the compartments of the ampule. Adjacent thereto, a syringe plunger portion I8 and a needle I1 have been shown. In this form of construction, it is not contemplated that the closure body 2| as illustrated in Fig. 1 will be employed for the aspirating action. Rather, the closure associated with the ampule will perform this function. However, the closure body 2| may be applied tothe free end of the ampule or by inserting the collar portion 24 into the bore at the outer end of such ampule. This will provide a bearing portion suitable for engagement with the thumb of the operator Without it being necessary that his thumb come into contact with the ampule edge.

The closure in Fig. 2 has been indicated by the reference numeral 28. Its body is formed preferably of rubber and may present on its outer surface a series of annular ring -or rib portions 2'9. The body is extended, as indicated at 3B, to project materiallybeyond the end of the ampule. This extended portion, which functions as a diaphragm or bulb part, may terminate in a relatively flat surface 3|. The area of this surface is preferably suiiiciently greatso that as the ampule is inserted into the bore of the barrel, the innerpointed end of the needle will be bound to contact the surface 3| even if such needle end is displaced to one side of the axis of the assembly.

' As will be apparent, with the projection of the ampule into the cylinder barrel, the pointed end of the needle will contact the flat surface 3| and continued projection will cause that needle end to pierce this surface and extend into the medicament body 21 contained within the ampule. Further projection will cause the plunger portion I8 to contact the surface 3|. Either at this time or previously, the needle will have been injected into the patient. If now, the doctor or technician causes the ampule body 25` to be slightly reciprocated with respect to the other portionsl of the syringe assembly, it is obvious that he will flex or squeeze and re-establish the bulb or diaf phragm portion 30. Consequently, an aspirating action will result. Therefore, if' the outer end of the needle I1 be in a vein, this will be evidenced under the aspirating action aforedescribed by a drop or so of blood emerging from the inner end of the needle. If aspiration Afails to develop such a showing, then the reciprocation of the ampule 5 may be discontinued and the `latter may be projected. Under such circumstances, theplunger portion I8 will displace the closure body 28 rear-Kl wardly. This will result in the latter functioning as a piston to express the medicament through the bore of the cannula I1 to thus resultinan injection.

In the form of construction shown substantially the same structure is present, as has been illustrated in Fig. 1. However, in such Fig. 3, the body of the closure 32 has its diaphragm portion pierced or recessedto mount a button or extension 34. The outer face ofthe` latter may b e convex and this extension may bev formed of rubber which may be of the same grade,

o r harder than that which forms the body 32. In any event, an actuating portion is providedby this structure which will permit of the iiexing of the diaphragm 33 'with minimum` effort. Such flexing may be resorted to throughout a greater range as a consequence of the extension 34 A,and accordingly a somewhat magniedaspirating action will result. This is desirable in the caseof long large bore needles having large volumes. -In this structure, an end closure for a syringe barrel has been shown as mounting the closure. Such closure might, if desired, be mounted by the end of an ampule, as in Fig. 2.

In the form of construction shown in Fig. 4, a double-ended ampule has again been illustrated. The outer ampule compartment is sealed by a closure body 35 which is internally recessed as in the constructions heretofore described and terminates in an end wall 36, which serves as a flexing portion. This end wall may be projected and retracted by the plunger portion 31 of a syringe partV 38, provided with a bore 39 to receive a needle (not shown) As illustrated, the side walls of the body 35 at points adjacent the end wall 36 are of a diameter less than the interior diameter of the ampule. Therefore, suflicient space exists to permit the end wall 36 to be retracted and then to project itself without the body 35 moving with respect yto the ampule 25. Accordingly, an aspirating action is achieved. In any event, it will be understood that, due to the proportions of the closure 35, a suliiciently rigid structure is presented such that a piercing of the end wall 36 may be effected by the inner end of the needle as the ampule is projected into the holder.

The structure illustrated in Fig. 5 shows a single-ended ampule 25 filled with medicament and having its outer end closed by a stopper constructed in accordance with the present teachings. This stopper includes a body 28 with a diaphragm portion 3U which extends beyond its mouth. As taught in my afore-identifled application for patent, this portion may be pierced by the needle l1 and may be flexed by the plunger portion I8'. In this manner, an aspirating action is achieved.

Thus, among others the several objects of the invention as specifically afore-noted are achieved. Obviously, numerous changes in construction and the rearrangement of the parts might be resorted to without departing from the spirit of the invention as defined by the claims.

I claim:

1. A closure by means of which aspiration may be effected when it is applied to a tubular member forming a part of a syringe assembly, said closure including a rear part-the outer face of which is disposable in sealing engagement with the bore face of said tubular memberand an integral forward part disposable beyond the end in Fig. *33,*

iol

of said member, said closure being formedT of resilient material and having a, recess extending from the end of the rear part through to the forward part thereof, said recess beingenlarged within the area of said latter part toprovidea bulb-chamber and a diaphragm integral with said forward part and dening the outer face of the same as Well as that of saidchamber.

2. A closure for use in connectiomwith the openV end of a tubularvmember formingfa part ofv a syringe-assembly, said closure including la body to beAd'isposedwithin the bore of said member to intimately engage the surface thereof, a resilient fand collapsible extended portion forming a part of one end of said body and tojproject beyond the end of the tubular member mounting said closure, an irnperforate and flexible wall across the outer end and forming apart` of said extended portion, such portion andbody being4 formed with a recess extending from tlieinner face of said end wall through to 4that 'l end of the body opposite to that at which saidextended portion is provided, said recess beingenlarged within .the area of said extended Pportion and adjacent said end wall to provide a bulbT-c'hamber, said imperforate end wall being adapted for reciprocation with respect to said body tovextend and collapse said portion and decrease and increase the area of said bulb-chamber to create a condition of subatmospheric pressure within the recess and a member to which said closure ls applied.

3. A resilient closure to seal the open end of a medicament-containing tubular ampule, said closure including a body to be disposed within the ampule bore to intimately engage the'surface thereof and slidably cooperate as a piston with said bore, a resilient and collapsible extended portion forming a part of one end of said body and to project beyond the end ofthe ampule mounting the closure, an imperforate and flexible end Wall across the outer end of said extended portion, such portion and body being 'formed with a recess extending from the inner yface of said wall through to that end of the bod'yopposite to that at which said extended portion is provided, said end wall and portion beingof less diameter than said body and saidj'fimperforate wall being adapted for penetration "by aj needle and engagement by a thrust portionfwhereupon said portion will be collapsed with respect to the closure body and may thereupon extend with respect to that body as the resiliency of the extended portion reestablishes the position of the wall, such projection causing the creation of a subatmospheric condition within the recess and an ampule mounting said closure.

4. A resilient closure to seal the open end of a medicament-containing tubular ampule, said closure including a body to be disposed within the ampule bore to intimately engage the surface thereof and slidably cooperate as a piston with said bore, a resilient and collapsible extended portion forming a part of one end of said body and to project beyond the end of the ampule mounting the closure, an imperforate and flexible end wall across the outer end of said extended portion, such portion and body being formed with a recess extending from the inner face of said wall through to that end of the body opposite to that at which said extended portion is provided and being enlarged within the area of said portion and adjacent said wall to provide a bulbchamber, said end wall and portion being of less diameter than said body and saidimperforate Y 7 wall being adapted for penetration by a needle to extend into,v said bulb-chamber, said end, wall beingr'noreover adapted for engagement by a thrust portion which when so engagingl the end wall will ca use a retraction of the latter with respect 'to the closure bodi7 andupon release of said thrust portion-a projection of the end wall, as the-resiliency of the extended portionere-establishes'the position of the wall, such end wall projection causing an expansion of the bulbl chamber to create a subatmospheric condition Wit-hin `the recess and an ampule mounting said closure..

5., A resilient closure for application to the open end of a tubular barrel forming a part of a :syringe assembly, said closure including a heasded-body, a circular iange forming a part of said body andA of a diameter to sealingly engage the bore face of said barrel, the head of said .body having a diameter greater than that ofvsai'dfflange and being formed with an enlarged recess communicating with .the space defined by said flange, an outwardly bowed flexible and resilient wall defining; the outer end of said l 8i recess and said ,wall-under pressure applied to this outer face-fating as a diaphragm to be flexed inwardly :andupon the release of such pressuremoving Voutwardly to create a condition of subatmospheric pressure within said chamber and within a barrel to which such clo-y sure is applied.

MARSHALL L. LOCKHART.

REERENCES CITED The following ,references are of record in the file of this patent:

UNITED STATES PATENTS 

